Biologics

StemGenex Product Does Not Meet Legal Requirements: FDA

David McFarland

— 2 min read
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A 1/16-1/26 FDA inspection at StemGenex Biologic Laboratories, San Diego, CA, determined that the company processes adipose tissue from donors for autologous use and also processes stromal vascular fraction (SVF) that is administered in a variety of ways. A 10/31 Warning Letter says the company says the SVF product is intended to treat a variety of diseases and conditions. As a result, the letter says, the SVF product is a drug as defined in the Federal Food, Drug, and Cosmetic Act, and is a biological product as defined in the Public Health Service Act. The SVF also is a human cell, tissue, or cellular or tissue-based product as defined in agency regulations, but does not meet criteria set for structural tissue.

The company does not have a valid BLA or IND for its product, FDA says. The letter also says agency investigators documented evidence of significant deviations from current good manufacturing practice, including: 

  •          failing to establish and follow appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile, including procedures for validation of all aseptic and sterilization processes;
  •          failing to establish written production and process control procedures designed to assure that drug products have the identity, strength, quality, and purity they purport or are represented to possess;
  •          failing to perform appropriate laboratory testing, as necessary, of each batch of drug product required to be free of objectionable microorganisms;
  •          failing to have separate or defined areas or such other control systems for operations as are necessary to prevent contaminations or mix-ups during the course of manufacturing and processing operations;
  •          failing to have a system for monitoring environmental conditions in an aseptic processing area;
  •          failing to maintain laboratory controls that include establishment of scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure the components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity;
  •          failing to ensure that each lot of components, drug product containers, and closures are withheld from use until the lot has been sampled, tested, or examined, as appropriate, and released for use by the quality control unit;
  •          failing to establish and follow written procedures describing in sufficient detail the receipt, identification, storage, handling, sampling, testing, and approval or rejection of components and drug product containers and closures;
  •          failing to establish a quality control unit that has the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated; and
  • ·        failing to establish and follow written procedures describing handling of all written and oral complaints regarding a drug product.

The letter acknowledges the company’s commitment to implement comprehensive corrective actions in response to the inspection observations and says the agency is unable to determine the adequacy of its corrective actions to date due to the limited information provided for review.

StemGenex was told to take prompt action to correct the violations and to respond with a list of any steps taken to correct the violations and prevent their recurrence, with documentation of each step, and a timetable for completion.

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